Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-29.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Aug 2023 – 29 Aug 2023 | Biologics | 483 | View 483 → |
| 18 Feb 2019 – 26 Feb 2019 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Aug 2023
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Roger F Zabinski, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Roger F Zabinski1 insp.
Laurel A Beer1 insp.
Christian J Sauder1 insp.
Christian Lynch1 insp.
Richard A Lewis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Burgwedel Biotech GmbH's 2 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat